Merrill Lynch Global Healthcare Conference February 4, Shire Pharmaceuticals Group plc

Transcription

1 Merrill Lynch Global Healthcare Conference February 4, 2003 Shire Pharmaceuticals Group plc

2 Comment on the Safe Harbor Statement under the Private Securities Litigation Reform Act of 995 The statements made during today s presentation, or in response to questions during the Question & Answer period, that are not historical facts are forward-looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event that such risks or uncertainties materialise, Shire s results could be materially affected. The risks and uncertainties include, but are not limited to, risks associated with the inherent uncertainty of pharmaceutical research, product development and commercialisation, the impact of competitive products, including but not limited to the impact of same on Shire s ADHD franchise, patents, government regulation and approval, including but not limited to the expected approval date of lanthanum carbonate (Fosrenol/Fosnol) and other risks and uncertainties detailed from time to time in periodic reports produced by Shire, including the Annual Report filed on Form 0K by Shire with the Securities and Exchange Commission. Trademark Information: Unless otherwise indicated, certain product names set out in this document are trademarks of the Shire Group, many of which are the subject of trademark registrations in certain territories. These names include, but are not limited to, Adderall, Adderall XR, Agrylin, Colazide, Carbatrol, DextroStat, Dirame, Fluviral S/F, Fosrenol, Foznol, MMX, Pacis, Pentasa, ProAmatine, Solaraze, Troxatyl, EnSoTrol, Microtrol, OptiScreen, ProScreen, and Solutrol. 3TC, Epivir, Combivir, Trizivir, and Zeffix are trademarks of GlaxoSmithKline. Reminyl and Concerta are trademarks of Johnson & Johnson. Aricept is a trademark of Pfizer / Eisai. Exelon is a trademark of Novartis. NeisVac-C is a trademark of Baxter International. Adept is a trademark of ML Laboratories. 2

3 Agenda Focused Strategy Adderall XR Therapeutic Area Development Competitive R&D pipeline 2003 Newsflow 3

4 Unique Strategy Functional Focus R&D Search Marketing Technology Focus Therapeutic Focus CNS Oncology Anti-Infectives GI Others Geographic Focus Customer Focus Specialty Doctors * No current presence Small Molecules Biologics Advanced Drug Delivery United States Germany United Kingdom France Italy Spain Canada Japan* 4

5 % 80.0% 70.0% 60.0% 50.0% 40.0% 30.0% 20.0% 0.0% 0.0% Life Cycle Conversions (TRx)* Lexapro Adderall XR Clarinex Paxil CR Percent Conversion to Next Generation Product * Source: Bear Stearns Week of Launch Detrol LA Nexium Glucophage XR Glucovance

6 US ADHD Market - Initial 2003 Trends Market Share changes over first 4 weeks of 2003* Adderall XR Ritalin LA Metadate ER Desoxyn Focalin Dexedrine Tablet Cylert Ritalin SR Methylin ER Dextrostat Dexedrine Spansule Metadate CD Methylin Concerta Generic Pemoline Methylphenidate SR Ritalin Dextroamphetamine Methylphenidate Adderall Generic Adderall (All makers) Atomoxetine Market share (week of January 24, 2003): 2.65% * Source: IMS Health (weeks ending January 3, 2003 to January 24, 2003) Market Share Change (%) 6

7 ADHD Market Dynamics Increased Rx growth over prior periods Q02: 0% Q202: 6% FY02: + 4% Q302: 7% Q402: 5% Substantial untreated patient population Paediatric market: 65% untreated (2.6 million patients) Adult market: 95% untreated (7.6 million patients) 7

8 Competitive Strengths of Adderall Franchise >27 million prescriptions* Rapid onset Flexible dosing regimen Proven efficacy Good safety record Proven marketing * Source: IMS Health, January 996 to December

9 Adderall versus Adderall XR Adderall* no exclusivity or patent protection in recent years no reporting requirement from a generic applicant to Shire at the time of an ANDA submission no knowledge when a competitor submitted an ANDA Adderall XR is in a totally different and stronger position! * 997 to 200 perspective 9

10 Adderall XR: Current Protections Hatch-Waxman exclusivity on current indication: October 2004 and Pharmaceutical composition and formulation patent November 208 0

11 snda for adult indication of Adderall XR Shire submitted on a supplementary NDA for the use of Adderall XR in adults. This submission is for specific strengths for use in adults, is supported by clinical data and is expected to attract its own 3 year Hatch-Waxman protection Subject to FDA approval and the assumption that this approval could be received by early 2004, this additional Hatch-Waxman protection could extend to early 2007.

12 Paediatric Extension Subject to the FDA and Shire agreeing an appropriate clinical trial programme for Adderall XR, Shire could receive a 6 months extension to the Hatch-Waxman protection period for its Adderall XR approvals. 2

13 FOSRENOL EU Review of submission continues FOSRENOL EU launches 2003* US Review of submission continues FOSRENOL US launch 2003* Active discussions ongoing with both regulatory authorities Opinion leader support remains strong Strong Phase III data on Fosrenol presented at 2002 ASN * Subject to regulatory approval 3

14 Therapeutic Area Development CNS ADHD Adderall XR Ongoing* M&A opportunities would diversify risks away from Adderall XR Other Carbatrol (Epilepsy) manufacturing issues resolved, re-launch in 2003 SPD47 bipolar disorder indication currently in Phase III Gastrointestinal Additional UC projects under development include: Pentasa 500mg Colazide 500mg SPD 476 MMX formulation SPD 480 rectal formulation M&A opportunities would bridge to new product launches * Commercially sensitive, no further details released 4

15 Therapeutic Area Development Anti-infectives Royalty stream provides cashflow SPD 754 / SPD 756 provide opportunity to build HIV franchise Oncology Agrylin generic competition in the US (3/2004), growth ex-us Troxatyl provides opportunity to build franchise Renal Disease Fosrenol* provides opportunity to build franchise M&A opportunities to build out franchise * Subject to regulatory approval 5

16 Therapeutic Area Development Vaccines Fluviral global expansion Berna Biotech commercial agreement M&A opportunities would fund R&D development and bridge to new product launches 6

17 R&D Pipeline balance Therapeutic Area PC/Phase I Phase II and beyond Total CNS Anti-infectives 6 7 Oncology GI Other 0 Total full development projects 7

18 Shire s Strong R&D Pipeline vs. Competition* 22 4 ** Pipeline by Company PC PII PI PIII Shire Merck KGaA 2 8 Allergan Forest Elan Recordati Lundbeck Novo Altana Orion Galen UCB * Source: Goldman Sachs as per September 2002 ** includes 2 projects in the registration phase 4 3 Alcon King Medicis 8

19 Shire s Strong Pipeline vs. Competition* 42.0 Weighted Pipeline Index by Company ** Merck KGaA Shire Forest Elan Allergan Recordati Novo Orion Lundbeck * Source: Goldman Sachs as per September 2002 * * Weighting: PC = 0., PI =, PII = 2, PIII = Altana UCB Galen King Alcon Medicis

20 Major Newsflow in 2003* Shire performance in ADHD market Fosrenol regulatory progress Management succession Progression of late stage R&D pipeline * Not listed chronologically 20

21 Summary Clear strategic direction Development of therapeutic areas Emerging late stage R&D pipeline Major newsflow in

22 Shire Pharmaceuticals Group plc 22